The development of concentrated protein formulations comprising proteins at a concentration of greater than 100 mg/mL presents many challenges. At such high concentrations, these proteins are restricted by solubility, administration volume and manufacturing limitations, stability issues, and delivery obstacles exist. Developing formulations in which the component protein is at present in high concentration may also present aggregation problems. Concentrated protein formulations specific for injectable administration present a particular complication in that they tend to be highly viscous. Not only do these formulations present potential difficulties during subcutaneous administration to an individual, but also during preparation and manufacture.
There is a need for highly concentrated protein formulations having low viscosity, particularly for the ready administration of protein-based drugs and biologics to subjects via parenteral routes. The present invention provides a solution to this need.